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临床试验/NCT05921981
NCT05921981已完成不适用

Comparison of the Effectiveness of White Noise and Multisensory Stimulation in Retinopathy Examination

Akdeniz University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2023年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Neonatal Pain

研究概览

简要总结

This study aimed to compare the effectiveness of two interventions, white noise, and multisensory stimulation, during retinopathy examinations on premature infants. Retinopathy is a common eye disorder among premature infants, which can cause visual impairments if not addressed. The research used a randomized controlled experimental design, with premature infants randomly assigned to either the white noise or multisensory stimulation group or control group. Physiological responses, behavioral indicators, and the pain of the retinopathy examination were measured. Trained healthcare professionals conducted the investigations in a controlled environment, and statistical analyses were employed to compare the outcomes between the three groups. The findings of this study have the potential to inform the development of more effective and well-tolerated examination protocols for premature infants, leading to improved visual outcomes and overall well-being for this vulnerable population.

详细描述

This study aimed to compare the effectiveness of white noise and multisensory stimulation in retinopathy examination on premature infants. Retinopathy is a common eye disorder among premature infants that can lead to long-term visual impairments if left untreated. Therefore, finding effective interventions for retinopathy examinations is crucial for improving the overall visual health of these infants.

A randomized controlled experimental design was employed, with premature infants as the study participants. The infants were randomly assigned to three groups: the control group, the white noise group, and the multisensory stimulation group. The white noise group received auditory stimulation through the presentation of white noise, while the multisensory stimulation group received additional visual and tactile stimuli during the retinopathy examination.

Several outcome measures were used to evaluate the effectiveness of the interventions. These measures included physiological responses (e.g., heart rate, blood pressure), behavioral indicators (e.g., eye movement, crying), and overall examination success rate. The examination success rate was defined as the ability to complete the retinopathy examination without disturbances caused by infant distress or movement.

The study employed trained healthcare professionals who performed retinopathy examinations using standardized procedures. Data collection was conducted in a controlled environment to ensure consistency across three groups. Statistical analyses, such as ANOVA and chi-square tests, were employed to compare the outcomes between the three groups.

The findings of this study have the potential to contribute to the development of effective and well-tolerated retinopathy examination protocols for premature infants. By comparing the effects of white noise and multisensory stimulation, the study aims to provide insights into the most suitable intervention that can optimize the examination process, improve examination success rates, and minimize potential discomfort or distress experienced by infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
32 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Premature newborns with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g, according to the records.
  • Neonates undergoing a first-time eye exam to screen for retinopathy of prematurity.
  • Newborns with their mother.
  • Newborns who have not been fed in the last hour.

排除标准

  • Newborns who need cardiopulmonary resuscitation (CPR) during the exam.
  • Newborns experiencing apnea at the time of examination

结局指标

主要结局

Neonatal Pain

时间窗: first 30 minutes during procedure

The Premature Infant Pain Profile (PIPP) is a validated and widely used tool designed to assess pain in preterm infants. It takes into account physiological and behavioral indicators that are indicative of pain in this population. The PIPP scale includes the evaluation of facial expressions, gestational age, heart rate, oxygen saturation, and behavioral state to assess pain levels. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0-6 points, the pain is considered mild, 7-12 points moderate, 13-21 points severe.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halil Ibrahim Tasdemir

Assistant Professor

Akdeniz University

研究点 (2)

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